WHO-GMP Validated CDMO · Human Formulations

Human Formulations Manufacturing & CDMO Solutions

We are a leading pharmaceutical Contract Development and Manufacturing Organization (CDMO) delivering proprietary formulation science, rigorous quality compliance, and commercial-scale manufacturing across 60+ dosage formats.

High-Speed Cleanroom Pharmaceutical Manufacturing Line
20+ Yrs
CDMO Track Record
1,000+
DCGI Approvals
Strategic CDMO Partner

End-to-End Product Development & Proprietary Formulations

We are a pharmaceutical contract development and manufacturing organization (“CDMO”) offering a comprehensive range of pharmaceutical products and services in India and overseas.

As one of the leading CDMOs in India, we own the intellectual property for the manufacturing processes of several of our formulations, and our core business is focused on providing end-to-end product development and manufacturing solutions to our clients.

Some of our other services include formulation research and development (“R&D”), preparation and filing of regulatory dossiers in the Indian and global markets, and other testing services.

Proprietary IP
Proprietary Process IP

We own the intellectual property for several formulation processes, ensuring formulation exclusivity and process defensibility.

Turnkey Scale
End-to-End Solutions

Seamless progression from formulation R&D and pilot batching through to high-velocity commercial manufacturing output.

Global CTD
Indian & Global Dossiers

Full-scope preparation and filing of regulatory dossiers in the Indian and international markets for expedited market launch.

GLP Testing
GLP Analytical Testing

Equipped with modern analytical instrumentation, stability testing chambers, and validated batch testing release services.

WHO-GMP Cleanroom Formulation Line & Automated Packaging
Class 100,000 Cleanroom HVAC
Comprehensive CDMO Scale
India & Global Healthcare Supply
20+ Years CDMO
60+ Dosage Forms
1,000+ Approvals
Verified Benchmarks

Company Highlights & Key Statistics

Demonstrated scale and regulatory leadership powering trusted global healthcare supply partnerships.

20+
Years CDMO Experience
Decades of manufacturing excellence and contract formulation stewardship.
60+
Dosage Forms
Commercial formulations engineered with over 60 versatile dosage formats.
65+
Countries Worldwide
Comprehensive supply presence spanning healthcare markets across over 60 countries.
220+
Innovative Formulations
Proprietary and complex formulations developed across diverse therapies.
1000+
DCGI Approvals
Documented regulatory approvals marking sustained progress in drug development.
Scientific Rigour & Quality

Research & Development (R&D) and Quality Assurance

Our unwavering commitment to cutting-edge research and development drives innovation, enabling us to create safe, effective, and high-quality healthcare solutions. Every product undergoes rigorous quality assurance processes to ensure the highest standards of efficacy, safety, and regulatory compliance before reaching patients.

Pharmaceutical R&D Laboratory Formulation and Chemical Synthesis
5 Dedicated R&D Units
220+ Innovative Formulations Engineered

3.1 Research and Development

Product Development & Formulation Innovation

5 Research and Development (R&D) Units drive our continuous efforts in product development, ensuring innovative solutions, rapid pre-formulation screening, and optimal bioavailability.

Pre-Formulation & QbD Screening Systematic Quality by Design framework optimizing solubility, stability, and therapeutic delivery.
Bioequivalence (BE) Studies & Clinical Batches Pilot-scale synthesis, dissolution profiling, and regulatory-ready clinical trial material production.
Proprietary Process IP Synthesis In-house owned intellectual property for novel, complex, and high-barrier formulation pathways.
GLP Analytical Chemistry Quality Control Testing Laboratory
Validated cGMP & GLP Compliance
0.00% Defect Release Benchmark

3.2 Quality Assurance

Compliance, Testing & Continuous Improvement

Compliance, rigorous testing, and continuous improvement ensure exceptional quality and high standards for our products before reaching patients worldwide.

Full GLP Analytical Testing Equipped with HPLC, Gas Chromatography (GC), FTIR, and spectrophotometric testing suites.
ICH Climatic Stability Chambers Real-time and accelerated stability chambers covering ICH climatic zones I through IV.
Continuous IPQC & CoA Release In-process quality controls, 100% digital batch traceability, and certified finished-product release.
Analytical Suite & Testing Instrumentation
High-Performance Liquid Chromatography (HPLC) Gas Chromatography (GC) Dissolution Profiling (Apparatus I & II) Photostability & Humidity Chambers FTIR Spectrophotometry TOC & Water Analysis Microbiology Sterility Testing
End-to-End Capabilities

Our Comprehensive Pharmaceutical Solutions

Tailor-made pharmaceutical solutions catering to diverse therapeutic needs, seamlessly integrating research, development, and manufacturing.

01 / PILLAR

Research

Research activities supporting pharmaceutical product development, API synthesis, and drug delivery optimization.

02 / PILLAR

New Formulation

Development of new formulations tailored for diverse therapeutic needs and enhanced patient compliance.

03 / PILLAR

Clinical Trials

Support for clinical trial requirements and materials, producing reliable and validated trial batches.

04 / PILLAR

Scale-Up

Scaling up formulations and manufacturing processes seamlessly from pilot batches to high-volume commercial production.

05 / PILLAR

Regulatory & Mfg

Regulatory approval support and commercial manufacturing under strict international cGMP standards.

Global Standards

Committed to Regulatory Compliance

Our dedicated regulatory affairs team provides comprehensive guidance across international health authority submissions, dossier preparation, and continuous GMP surveillance.

Regulatory Strategy Development
Adherence to Good Manufacturing Practices (GMP)
Dossier Compilation and Submission Management (CTD / eCTD)
Regulatory Audits and Assessments
Global Regulatory Approvals (DCGI & International Health Authorities)

Initiate Regulatory Consultation

Consult with our regulatory and compliance specialists to expedite your drug master files and commercial dossier clearances.

Contact Us
Streamlined Execution

From Concept to Commercialization with Regulatory Expertise

Streamlined development process from concept to commercialization, providing expert guidance in navigating regulatory pathways.

01

Formulation Development

Creating innovative and effective pharmaceutical formulations to meet diverse medical needs and therapeutic profiles.

02

Clinical Trial Material

Delivers reliable clinical trial materials, contributing to the progress of safe and effective therapies across clinical phases.

03

Scale-up and Tech-Transfer

Scales up production processes and expertly transfers technologies to ensure seamless transitions in manufacturing.

04

Analytical Chemistry

Advanced analytical techniques to ensure the quality and integrity of products in development and production stages.

05

Commercial Manufacturing

State-of-the-art manufacturing facilities, enabling the large-scale production of pharmaceutical products for distribution.

06

Formulation Development & Support

Ongoing formulation optimization, lifecycle management, and post-marketing regulatory compliance support.

Core Competencies

Our Expertise

We specialize in pharmaceutical innovation, offering cutting-edge R&D, stringent quality control, and regulatory compliance. Our diverse expertise ensures the development of high-quality formulations across various therapeutic segments for global markets.

Manufacturing

Precision, dedication, expertise, and innovation define our commitment to excellence in every product we create.

Innovation

We are driven by a relentless pursuit of creativity, continually pushing boundaries and pioneering the future.

Quality

Our unwavering commitment to uncompromising standards ensures guaranteed satisfaction for our customers.

Regulatory

We uphold the highest ethical and legal standards, consistently delivering on our promise of compliance and integrity.

R&D

We advance through continuous research and development efforts, staying at the forefront of pharmaceutical innovation.

Dosage Portfolio

Diverse Dosage Forms for Enhanced Pharmaceutical Delivery

Offering a comprehensive range of 60+ dosage formats engineered to meet precise patient pharmacokinetic requirements, with proven capability in complex and high-potency formulations.

High-Speed Pharmaceutical Tablets Compression Line
Solid Orals 9 Delivery Forms

Tablets

Precision compression lines engineered for modified, sustained, delayed, and multi-layered oral pharmacokinetic release profiles.

Available Formulations
Uncoated Film-coated Sugar-coated Sustained-Release Chewable Effervescent Tablet in Tablet Bi-layered Tablet in Tablet Pills
Pharmaceutical Dry Powder Sachet Filling Line
Dry Formulations 4 Delivery Forms

Powder

Dehumidified low-relative-humidity suites for hygroscopic, effervescent, and instant oral dispersion powders.

Available Formulations
Effervescent RH Powders Powders in Sachet Mouth Melt Powders Ready Mixes
Topicals, Creams, Gels and Dermatological Formulations
Semi-Solids 8 Delivery Forms

Topicals

Vacuum-homogenized compounding for dermatological creams, therapeutic ointments, medicated shampoos, and serums.

Available Formulations
Cream Ointments Gels Lotions Oils Shampoos Face Wash Serum
Aseptic Sterile Glass Vials and Ampoules Formulation Line
Aseptic / Parenteral 10 Delivery Forms

Sterile Preparation

Class 100 / Grade A isolator cleanroom filling of terminal sterilization & aseptic small and large volume parenterals.

Available Formulations
Liquid Injections Dry-Powder Injection Ampoules/Vials Pre-filled Syringes Multi-dose Vials Ear/Eye/Nasal Drops FFS/Three-piece Packs/Cap in Cap Single Unit UNIMS Packs Respules Large Volume Parenteral in 100 ML
Oral Liquid Syrups, Suspensions and Solutions Line
Liquid Orals 4 Delivery Forms

Oral Liquid

Closed-loop automated liquid compounding with calibrated dispensing, taste-masking, and stable suspension systems.

Available Formulations
Syrups Suspensions Solutions Oral Jellies in Sachet Oral Spray
Encapsulation Hard Gelatin and Softgel Capsules Line
Encapsulation 5 Delivery Forms

Capsule

High-speed encapsulation for hard gelatin, softgels, vegetarian shells, band-sealing, and pellet-in-capsule technology.

Available Formulations
Hard-Gelatin Soft-Gelatin Tablets in Capsule Twist-off Tips Vegetarian Capsules
Infrastructure

Facility Snapshot & Technical Capabilities

Cleanroom-certified infrastructure engineered for validated pharmaceutical output.

Manufacturing Lines Dedicated cGMP-compliant lines for tablets, capsules, dry syrups, oral liquids, sterile injectables, and topicals.
Batch Sizing & Scale Flexible pilot-scale validation runs (5 kg – 50 kg) through full commercial-scale production (up to multi-ton throughput).
Packaging Formats Alu-Alu blister, PVC/PVDC strip packing, amber glass/PET bottles, topical tubes, multi-dose vials, and pre-filled syringes.
Regulatory Licenses WHO-GMP · ISO 9001:2015 · ISO 14001:2015 · State FDA Manufacturing License · GLP QC Certification.
Quality Assurance / QC Fully equipped in-house analytical lab with HPLC, GC, FTIR, TOC analyzers, and 24/7 environmental stability chambers.

Ready to Scale Your Human Formulation with a Trusted CDMO?

Share your target dosage form, therapeutic category, or commercial batch requirements with our scientific and manufacturing leadership.